We must be united in the war against addiction! My mission is to unite organizations,support groups, and everyone else who needs a helping hand. I am here to educate equip and develop a Recovery resource Network. My hope is that everyone gets the help they need and no one is left behind or alone in their fight for freedom from addiction. Join me and lets fight the good fight! Our Philosophy: Instigate, Agitate, Educate, and Liberate!

Thursday, March 13, 2014

West Virginia Senator Calls on Head of HHS to Overrule Decision on Zohydro

West Virginia Senator Joe Manchin this week called on
Health and Human Services Secretary Kathleen Sebelius to overrule the
Food and Drug Administration’s (FDA) decision to approve the pure
hydrocodone drug Zohydro ER (extended release).Fox News reports Manchin sent Sebelius a letter
expressing his concern that Zohydro could add to the national epidemic
of prescription drug abuse. “Given the potentially imminent release of
Zohydro later this month, it is imperative that you act as soon as
possible to keep this dangerous drug off the market,” he wrote.Late last year, Manchin and three other senators wrote to the FDA,
saying they disagreed with the agency’s decision to approve the drug.
In October, the FDA approved Zohydro for patients with pain that
requires daily, around-the-clock, long-term treatment that cannot be
treated with other drugs. Drugs such as Vicodin contain a combination of
hydrocodone and other painkillers such as acetaminophen.In December, the attorneys general from 28 states asked the FDA to reassess its decision to approve Zohydro.A panel of experts assembled by the FDA voted against recommending
approval of Zohydro ER. The panel cited concerns over the potential for
addiction. In the 11-2 vote against approval, the panel said that while
the drug’s maker, Zogenix, had met narrow targets for safety and
efficacy, the painkiller could be used by people addicted to other
opioids, including oxycodone.The agency will require postmarketing studies of Zohydro ER to
evaluate the known serious risks of misuse, abuse, increased sensitivity
to pain, addiction, overdose, and death associated with long-term use
beyond 12 weeks.Zohydro is designed to be released over time, and can be crushed and
snorted by people seeking a strong, quick high. The opioid drug
OxyContin has been reformulated to make it harder to crush or dissolve,
but Zohydro does not include similar tamper-resistant features.